MIHIKA BHATT

** ******* ****, ******, **

Cell: 703-***-****; E-mail: ace3q2@r.postjobfree.com

OBJECTIVE

To obtain position in medical device field where I can apply my skills

in engineering

SUMMARY

7+ years of experience in product and process development of medical

devices

Worked as project and process lead, experience with design control

procedures, engineering and statistical analysis, mechanical testing

and developing test methods, designed instruments using CAD tools,

technical protocols and reports, process validation and yield

improvement

Solid leadership, teamwork and project management skills

WORK EXPERIENCE

LifeCell Corporation, Branchburg, NJ 08/12-

Current

Process Engineer

Working as process lead to improve performance of current medical

device products

Successfully completed root cause findings, Quality investigations and

CAPA's for production release

Completed process validation activities, reviewed and implemented

engineering order changes in processes

Support cross-functional teams to transfer processes from R&D to

production

Identified and lead yield improvement opportunities for business

benefits

Evaluated new supplier materials and partnered with Supplier Quality

to introduce materials in production

Performed statistical data analysis to identify the root cause of

failures and implemented proposed solutions in production

Proposed ideas to improve current processes and received two awards at

corporate competitions

Successfully launched statistical process control and monitoring

system for product lines and created a platform for cross-functional

team discussions for improvements. Partnered with IT/planning group to

develop a data base structure for data mining and analysis.

Lead and completed sterilization and packaging projects for business

excellence opportunity improvements

Euromed Inc., R&D, Orangeburg, NY 08/08-11/10

Project Engineer

Worked as project lead for new and existing wound care products from

design concept to launch

Generated project plans and executed activities with multi-functional

teams from QA, regulatory, sales, marketing and manufacturing in

accordance with agreed upon timelines.

Successfully completed projects from initial product design stage to

design transfer using FDA part 820 guidelines

Created design verification, validation, clinical reports and

conducted design reviews with all required functions

Generated test protocols, reports, test methods with lab personnel,

carried out lab experiments, executed gage R&R methods, analyzed test

results using statistical tool Minitab15.

Participated in internal and supplier audits to assure compliance with

FDA requirements, GMP, ISO quality standards and internal SOP's.

Created risk management files in compliance with ISO14971 by

performing risk analyses

Created or reviewed IQ/OQ/PQ validation documents and conducted in-

house validation runs

Co-ordinated and participated in in-house manufacturing runs for

quality or process improvement projects

Identified and qualified suppliers for product testing to minimize

production cost

Created and maintained design history folders in compliance with FDA

part 820 guidelines

Represented R&D for developing and revising documentation and

procedures required for release of finished goods and regulatory

submissions.

BD Medical Surgical Systems R&D, Franklin Lakes, NJ 07/07-

07/08

Research Engineer

Successfully drove projects to completion on time

Created project plans using Microsoft Project and executed projects

with cross-functional team including representatives from Quality,

Manufacturing, R&D, Regulatory and Medical Affairs

Represented R&D group for CAPA project implementation

Authored Design Verification documents and performed verification

testing of injection molded needle products

Designed test fixtures using Solid works 9.0, developed test methods,

executed tests using Instron machine, executed gage R&R methods

Performed Design of Engineering Studies and statistical analysis of

data using Minitab 15.0

Provided Finite Element Analysis solutions for development of product

specifications

Proficiency in writing technical protocols / reports and test

protocols / reports

Reviewed IQ/OQ/PQ validation documents with manufacturing group

Created Failure Mode and Effects Analysis (FMEA), gage R&R methods,

Measurement System Analysis (MSA), product part and assembly drawings,

Buy specifications, Engineering Change Order (ECO) documents to

release products

Developed documents per medical device design control procedures in

compliance with 21CFR Part 820 and maintained records in Design

History Folders

Stryker Orthopedics, Mahwah, NJ 07/06-

07/07

Advanced Technology Department - Tribology Lab

Research Assistant

Worked on wear analysis projects of prosthetic joint implant bearing

materials and lubrication conditions

Performed wear tests and analyzed test results using Microsoft Excel

Performed friction testing of implant materials using Orthopod

Assisted project engineers with concept development research projects

Experience in using wear simulators for hip and knee components

(femoral heads, acetabular cups, femurs, patella, knee inserts)

Designed prototypes of instruments and modified existing test

instruments using ProE Wildfire 2.0

Modified old drawings in ProE Wildfire based on design change

requirement

Responsible for maintenance and troubleshooting of lab equipments

Respironics Drug Delivery Division (Philips), Cedar Grove, NJ

07/05 - 07/06

Engineering Intern

Worked on design modification project on ProChamber valve with cross-

functional engineering team.

Executed test methods to verify compliance of respiratory medical

devices like Full range and Half range peak flow meters, OptiHaler,

OptiChamber devices with American Thoracic Society (ATS) and European

standards.

Created and maintained engineering reports and protocols.

Involved in manufacturing of medical device prototype using CGMP

guidelines.

EDUCATION

. Masters in Biomedical Engineering, Completed Spring 2007

New Jersey Institute of Technology, NJ GPA: 3.5/4.0

. Bachelor of Science in Mechanical Engineering, Completed Spring 2001

Maharaja Sayajirao University, INDIA GPA: 3.2/4.0

ACHIEVEMENTS

. Bhatt M., Lee R., Lancin P., Essner A., Wang A., Mont MA., Seyler

T., "Effect of Lubricant Protein Concentration on the wear of

UHMWPE Tibial Inserts in Knee Simulation", 6th Orthopedic Research

Society meeting at Honolulu, HI, October 2007

. Received two awards at Corporate competitions for submission of

best project ideas

SKILLS

Computer and Statistical Skills

. Green Belt certification, Statistical analysis using Minitab 17.0 and

Excel

. Certification training course on Auto Cad and Pro/Engineering Wildfire

4.0 from Cadd Center, October'2011

. Mechanical Design using Solid Works 9.0, Pro/Engineering Wildfire 2.0,

Pro/Mechanica

. Microsoft Project

Instrumentation Skills

. Experimental testing by Instron machine, Interferometer, Contact Angle

Measurement instrument, Coordinate Measuring Machine, Electrospinning

machine

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